The following data is part of a premarket notification filed by Okamoto U.s.a., Inc. with the FDA for Okamoto Condom.
| Device ID | K952393 |
| 510k Number | K952393 |
| Device Name: | OKAMOTO CONDOM |
| Classification | Condom |
| Applicant | OKAMOTO U.S.A., INC. 700 THIRTEENTH STREET, N.W. SUITE 1200 Washington, DC 20005 |
| Contact | Jeffery N Gibbs |
| Correspondent | Jeffery N Gibbs OKAMOTO U.S.A., INC. 700 THIRTEENTH STREET, N.W. SUITE 1200 Washington, DC 20005 |
| Product Code | HIS |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-05-22 |
| Decision Date | 1995-08-09 |